Disruptive, drug free treatment of knee osteoarthritis using novel materials and minimally invasive catheter delivery

Project Information

EmboSure

Grant agreement ID: 190167448

DOI

10.3030/190167448

Project closed

EC signature date 4 April 2022

Start date 1 May 2022

End date 30 November 2024

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 555 104,00

EU contribution

€ 2 488 572,80

Coordinated by

CRANNMED LTD
Ireland

Periodic Reporting for period 2 - EmboSure (Disruptive, drug free treatment of knee osteoarthritis using novel materials and minimally invasive catheter delivery)

Reporting period: 2023-05-01 to 2024-11-30

Summary of the context and overall objectives of the project

CrannMed is dedicated to addressing the enduring challenge posed by Knee Osteoarthritis (KOA), a prevalent and debilitating condition affecting a substantial portion of the EU and US population aged 55+. Currently, a staggering 30 million people, comprising approximately 14% of the population in the EU and US, are undergoing treatment for KOA.

Existing therapeutic approaches for KOA have proven inadequate in providing long-term relief. Alarmingly, the overwhelming majority of patients will inevitably experience treatment failure, necessitating invasive surgical interventions such as knee replacement for approximately two-thirds of individuals. Given the chronic nature of the disease, the absence of efficacious treatments, and the consequent impact on patient mobility and well-being, the economic burden of KOA is staggering, accounting for a substantial 1.5% of the global GDP.

Through research and engineering, CrannMed has developed SakuraBead resorbable microspheres that are precisely delivered using a specialised microcatheter directly to the inflamed region within the knee. SakuraBead's effectiveness initiates targeted short-term embolisation, reducing pain levels and restoring optimal well-being. It uniquely addresses the growing patient preference for no residual foreign objects within their bodies. SakuraBead also ensures that future medical treatments of the knee are not compromised due to permanent foreign objects remaining in situ.

CrannMed has demonstrated efficacy through rigorous pre-clinical testing. This notable achievement has been made possible through the establishment and validation of a state-of-the-art class 8 cleanroom within the CrannMed facility. With the critical infrastructure in place, the team is now poised to embark on the crucial phases of clinical evaluation and commercialisation. The vision is to establish SakuraBead as the gold standard for KOA treatment, surpassing traditional pharmaceutical-based therapies. Through comprehensive evaluation, CrannMed aims to demonstrate SakuraBead's effectiveness, secure regulatory approvals, and make it widely accessible to patients, reducing the burden on healthcare systems and improving patient outcomes.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

CrannMed has embarked on a pioneering endeavour by advancing the concept of resorbable embolisation. The innovative approach involved development of microspheres composed of organic biocompatible materials that possess the ability to degrade within the vasculature over a defined period. To precisely control the degradation process, we have incorporated an ingredient specifically designed to target the base material of these microspheres exclusively.

Through rigorous bench-testing and pre-clinical trials, CrannMed has acquired confidence in the efficacy and reliability of this technology. The resorbable embolisation capabilities of the microspheres have been conclusively demonstrated, showcasing their ability to perform the intended function with precision and efficacy. Most notably, once their purpose is fulfilled, these microspheres naturally dissolve, ensuring a clean and traceless conclusion to the treatment process.

To facilitate the development and commercialisation of this transformative technology, CrannMed has established an advanced class 8 cleanroom facility on-site. This state-of-the-art cleanroom plays a crucial role in the future manufacturing process, allowing the team to produce microsphere builds necessary for design verification and validation testing. CrannMed has established a high-volume manufacturing process and qualified a packaging concept which preserves the efficacy of the product. Due to the innovative resorbable nature of the SakuraBead product, customised test methods were developed so that performance in the patient could be predicted on the bench. Through scientific and engineering expertise this has been successfully accomplished. Design testing for SakuraBead is now complete that demonstrates its effectiveness, safety, and readiness for human evaluation. By collaborating with a renowned Clinical Research Organization (CRO), CrannMed is progressing towards clinical trials, prioritising medical science and patient outcomes. CrannMed has established a Quality Management System that supports the international regulatory requirements for clinical studies and commercialisation

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

CrannMed has achieved significant milestones in validating the design of SakuraBead through successful pre-clinical models. It inhibits neo-vessel growth while preserving crucial arteries. Clinical evaluation is now a priority to confirm its mechanism of action and effectiveness in providing patient pain relief. Gathering human use data and conducting pivotal studies will support SakuraBead's market introduction, demonstrating its superiority over existing pharmaceutical alternatives.

Simultaneously, efforts are underway to establish the on-label use of SakuraBead in Genicular Artery Embolization (GAE) procedures in the US. Regulatory approval in the US and pursuing the EU CE mark will expand its availability globally. Comprehensive international patent applications have been filed to protect the technology and manufacturing process, ensuring exclusivity, and promoting innovation.